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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

1. What Syntocinon® is and what it is used for

- Pharmacotherapeutic group:

SYNTOCINON® 5 IU/mL Solution for injection, contains an active substance called oxytocin.

Syntocinon belongs to a group of medicines called oxytocics that stimulate contraction of the womb (uterus). It is identical with oxytocin, a natural hormone released by the pituitary gland.

-Therapeutic indications:

-Syntocinon is used:

·To start or help contractions during childbirth (labour).

·To help in the management of a miscarriage.

·To prevent and control bleeding after delivery of your baby.

·During a caesarean section.

If you have any questions about how Syntocinon works or why it has been prescribed for you, ask your doctor.

- How Syntocinon works:

Syntocinon works by stimulating rhythmic contraction of the womb during labor and after delivery.

-Monitoring Syntocinon treatment:

During Syntocinon infusion, both you and your baby will be closely monitored to prevent complications so that the dosage can be adjusted to the individual response.


Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. It is important to tell your doctor if you have other medical problems or if you are taking other medicines.

 

a. Syntocinon should not be used:

If you are allergic (hypersensitive) to oxytocin or to any of the ingredients of Syntocinon listed at the end of the leaflet under What Syntocinon is

· If your doctor thinks that inducing or enhancing contractions would be unsuitable for you. For example:

- If you already have unusually strong (hypertonic) contractions

- If your baby is short of oxygen (fetal distress) and delivery is not imminent

- If your doctor advises against normal labor and/or vaginal delivery

- Where there are obstructions that may prevent delivery

 

 

·If there are maternal or fetal reasons for cesarean delivery. For example:

- If your baby’s head is too large to fit through your pelvis (cephalopelvic disproportion)

- If your baby is wrongly positioned in the birth canal (malpresentation)

- If the placenta lies near or over the neck of your womb (placenta previa)

- If your baby lacks oxygen due to blood vessels running across the neck of your womb (vasa previa)

- If the placenta separates from the womb before the baby is born

(abruption)

- If there are one or more loops of umbilical cord between the baby and neck of the womb, before your waters break (cord presentation) or afterwards (cord prolapse).

- If your womb is over-extended and more liable to burst (rupture), for example if you are carrying more than one baby (multiple pregnancy) or have too much water (amniotic fluid) in your womb (polyhydramnios)

- If you have had five or more previous pregnancies (grand multiparity) or if your womb is scarred by a previous cesarean section or other surgery

- If you have been given medicines called prostaglandins (used to bring on [induce] labor or treat stomach ulcers). Syntocinon should not be used for 6 hours after vaginal prostaglandins as the effects of both drugs may be increased

 

If any of these apply to you, you should not receive Syntocinon and you should consult your doctor. If you think you may be allergic, ask your doctor for advice.

 

b. Take special care with Syntocinon

· Syntocinon should be administered by a health care professional in a

hospital setting where a qualified health care professional can monitor your contractions and handle emergencies appropriately

Syntocinon should not be used for prolonged periods

· If it fails to increase your contractions (oxytocin-resistant uterine inertia)

· If you have high blood pressure, protein in the urine, and swelling (preeclampsia)

· If you have severe heart and/or circulation problems (severe cardiovascular disease)

Syntocinon should be used with caution

- If you are prone to chest pain (angina, caused by insufficient blood flow to heart) due to pre-existing heart and/ or circulation problems (cardiovascular disease)

- If you have a known irregular heart beat (‘long QT syndrome’) or related symptoms, or are taking medicines known to cause the syndrome

- If you are given a rapid intravenous injection (bolus), it may cause low blood pressure (hypotension), a sudden brief sensation of heat (flushing), often over the entire body, and an increased heart rate (reflex tachycardia)

When Syntocinon is given to induce and enhance labor:

· It should be given only by intravenous infusion

· The infusion rate should be set to maintain a contraction pattern similar to normal labor and adjusted to individual response. Excessive doses may cause very strong continuous contraction (tetany) and possible bursting (rupture) of the womb with serious complications for your baby (distress or death) and yourself

Take particular care with Syntocinon:

· If you have been warned by a doctor or midwife that normal delivery may be difficult as your baby’s head may be too large to fit through your pelvis (cephalopelvic disproportion)

· If your womb starts to contract less strongly during labor (secondary

uterine inertia)

· If you have a mild or moderate pregnancy-induced increase in blood

pressure or heart and/or circulation problems (cardiovascular disease)

· If you are over 35 years of age

· If you have had a cesarean section through an incision just above the edge of the bladder (lower segment cesarean section)

· If you have kidney problems (Syntocinon can cause water retention)

· If you have had complications during your pregnancy

· If you are more than 40 weeks pregnant

 

If any of these conditions apply to you, tell your doctor as soon as possible.

· Syntocinon may rarely cause abnormal blood clotting, bleeding, and

anemia (disseminated intravascular coagulation)

· High doses of Syntocinon may force water from your womb (amniotic fluid) into your blood circulation (amniotic fluid embolism) during labor and/or delivery

· High doses of Syntocinon over a prolonged period while drinking or receiving large volumes of fluid may cause

· severe abdominal fullness and difficulty in breathing (acute pulmonary

edema)

· a low level of salt (sodium) in the blood (hyponatremia)

· Latex Allergy:

The active substance in Syntocinon might cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Please tell your doctor if you know you are allergic to latex.

c. Taking other medicines

Tell your doctor or health care professional about the other medicines you

are taking or have recently taken, including those you may have bought over the counter. It is especially important that your doctor knows if you are receiving any of the following:

· Anesthetic medicines for local or regional pain relief, in particular caudal

anesthesia (injection of local anesthetic below the tail end of the spinal cord and around the spinal nerve roots) for pain relief during labor: Syntocinon may increase the blood vessel-narrowing effect of these medicines (vasoconstriction), and cause an increase in blood pressure

· Medicines called prostaglandins (used to bring on [induce] labor or treat

stomach ulcers) and similar drugs: Syntocinon may increase their contractile effect on your womb

· Medicines that can cause an irregular heart beat (prolonged QT interval): Syntocinon may increase this effect

· Gas or vaporous liquid anesthetics that cause general anesthesia when

inhaled (such as halothane, cyclopropane, sevoflurane or desflurane) may weaken the contractile effects of Syntocinon on your womb

d. Elderly (65 years and over)

· There is no information on use in elderly patients. Syntocinon is not intended for use in the elderly

e. Children and adolescents (2 years to 17 years)

· There is no information on use in children (2-11 years). Syntocinon is not intended for use in children

· There is no information on use in adolescents (12-17 years). Syntocinon is not intended for use in adolescents.

f. Pregnancy and breast-feeding

Pregnancy

Based on wide experience with the drug, its chemical structure and

pharmacological properties, Syntocinon is not expected to present a risk to the baby when used as indicated. It should only be used to initiate labor under medical supervision.

 

Breast-feeding

Syntocinon may be found in small quantities in breast milk but is not expected to have harmful effects because it is rapidly inactivated by your baby’s digestive system. This explains why Syntocinon is safe for your newborn baby.

Ask your doctor, health care provider or pharmacist for advice before taking any medicine.

 

g. Driving and using machines

Syntocinon may induce contractions. Caution should therefore be exercised when driving or operating machines. Women with contractions should not drive or use machines.


Always use Syntocinon exactly as your doctor or health care provider has told you. You should check with your doctor, health care provider or pharmacist if you are not sure.

Syntocinon should be administered as an infusion or injection into a vein. It should be administered in a hospital setting where a qualified health care professional can monitor your contractions. See section 2 (Take special care with Syntocinon).

 

How much Syntocinon to use

Your doctor or health care professional will decide how much Syntocinon to use. For more information please refer to section 7 (Information for the health care professional).

 

When to use Syntocinon

Your doctor will decide when to use Syntocinon. You should check with your doctor or health care professional for more information. If you have the impression that the effect of Syntocinon is too strong or too weak, talk to your doctor or health care professional.

 

 

How to use Syntocinon

Syntocinon is usually diluted before use and given as an intravenous infusion (drip) or injection by a health care professional.

 

How long to use Syntocinon

Your doctor will decide how long you should use Syntocinon. If you are unsure, ask your doctor or health care professional.

 

a. If you have received more Syntocinon than you should

As this medicine is given to you in hospital, it is very unlikely

that you will receive an overdose. Were it to happen, however, it is an

emergency that can be handled immediately in the hospital setting.

Anyone accidentally receiving this medicine should visit a hospital accident and emergency department or doctor immediately, if possible with the left-over medicines or empty packet.

Excessive contractions caused by an overdose of Syntocinon may have the consequences mentioned in section

2 (Take special care with Syntocinon) and section 4 (Possible side effects):

· The placenta may separate too early from the womb (abruption)

· Some of the water around your baby (amniotic fluid) may be forced into your circulation (amniotic fluid embolism)

· Your baby may suffer distress, suffocation or death

· Your womb may tear or burst (rupture)

 

b. If you forget to use Syntocinon

As you will only be given this medicine by a doctor or health care professional,

you are unlikely to miss a dose. If you have any further questions on the use of this product, ask your doctor or health care professional.

 

c. If you stop using Syntocinon

Your doctor will decide when you should stop treatment with Syntocinon.

If you are unsure, ask your doctor or health care professional. If you have any further questions on the use of this product, ask your doctor, health care provider or pharmacist.


As with all medicines, side effects may occur with Syntocinon, although not everybody gets them. Your doctor may consider it necessary to treat the side effects of Syntocinon with other medicines.

 

Some side effects could be serious

Some side effects are rare

The following side effect may affect between 1 and 10 in every 10,000 patients:

· Severe allergic (anaphylactic /anaphylactoid) reaction associated with

breathlessness (dyspnea), low blood pressure (hypotension) or dangerously low blood pressure (shock)

 

The proportion of patients who may be affected by the following serious side effects is unknown

Effects in the mother

· Chest pain due to insufficient blood flow to the heart (angina)

· Irregular heartbeat (long QTc interval)

· Excessive contractions (hypertonicity)

· Continuous contraction (tetany)

· Bursting of the womb (uterine rupture)

· Fluid retention (water intoxication)

· Low sodium (salt) level in the blood (hyponatremia)

· Acute fluid overload in the lungs (acute pulmonary edema)

· A sudden brief sensation of heat, often over the entire body (flushing)

· Abnormal clotting, bleeding, and anemia (disseminated intravascular coagulation)

· Swelling of the face, lips, tongue, throat, and/or extremities (possible signs of angioedema)

If you experience any of these, tell your doctor straight away.

 

Effects in the baby

Excessive contractions may cause:

· Low sodium (salt) level in the blood (neonatal hyponatremia)

· Oxygen starvation (fetal distress)

· Suffocation from too little oxygen and/or too much car bon dioxide (asphyxia)

· Death

If any of these effects are severe, tell your doctor straight away.

 

Some side effects are common

These side effects may affect between 1 and 10 in every 100 patients.

· Headache

· Fast heart beat (tachycardia)

· Slow heart beat (bradycardia)

· Nausea

· Vomiting

If any of these affects you severely, tell your doctor.

 

Some side effects are uncommon

This side effect may affect between 1 and 10 in every 1000 patients.

· Irregular heartbeat (arrhythmia)

If any of these affects you severely, tell your doctor.

 

Some side effects are rare.

This side effect may affect between 1 and 10 in every 10,000 patients.

· Skin rash

If any of these affects you severely, tell your doctor.

If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.


· Solution for injection: store in a refrigerator (2-8°C).

· Keep Syntocinon out of the reach and sight of children.

· Do not use Syntocinon after the expiry date which is stated on the pack.

The expiry date refers to the last day of that month.

Information might differ in some countries


· The active substance in Syntocinon is oxytocin.

· The other ingredients are:

Sodium acetate trihydrate, glacial acetic acid, chlorobutanol, ethanol 94%, water for injections.


What Syntocinon looks like and content of pack Syntocinon is sterile, clear colourless solution and are supplied as solution for injection in ampoules. Each pack contains 5 x 1ml ampoules.

Marketing Authorization Holder

Mylan Pharma GmbH,

Turmstrasse 24,

6312 Steinhausen, Switzerland

 

Manufacturer

Steriscience Sp. z o.o.

ul. Daniszewska 10, 03-230 Warszawa, Poland

 


December 2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

 

ما ھو سِنتوسینون

سِنتوسینون 5 ®وحدة دولیة/ مللیلتر؛ محلول للحقن، یحتوي على مادة فعالة

تُسمَّى أوكسیتوسین.

ینتمي سِنتوسینون إلى مجموعة من الأدویة تُسمَّى معجِّلات الولادة وتعمل على

تحفیز انقباضات الرحم. وھو مماثل لأوكسیتوسین، الھرمون الطبیعي الذي

تفرزه الغدة النخامیة.

 

ما ھي استعمالات سِنتوسینون

سِنتوسینون یستخدم:

• لتحریض أو تسھیل انقباضات الرحم أثناء الولادة )المخاض(.

• للتعامل مع الإجھاض.

• للوقایة من النزف ولعلاجه بعد ولادة الطفل.

• أثناء العملیات القیصریة.

إذا كانت لدیك أي أسئلة عن الكیفیة التي یعمل بھا سِنتوسینون أو عن سبب

وصف ھذا الدواء لك، برجاء أن تسألي طبیبك.

 

كیف یعمل سِنتوسینون

یعمل سِنتوسینون من خلال تحفیز انقباضات الرحم المنتظمة أثناء الولادة

وبعد الولادة.

المراقبة أثناء علاجك بواسطة سِنتوسینون

أثناء إعطائك سِنتوسینون بالتنقیط، ستتم مراقبتك أنتِ والمولود بكل دقة لمنع

حدوث مضاعفات بحیث یتم تعدیل الجرعة تبعاً للاستجابة الفردیة.

 

 

-2 قبل أن تتلقي سِنتوسینون®

التزمي بجمیع تعلیمات طبیبك بكل دقة. ھذه التعلیمات قد تكون مختلفة عن

المعلومات العامة المذكورة في ھذه النشرة.

من الضروري أن تخبري طبیبك إذا كانت لدیك مشاكل طبیة أخرى أو إذا كنتِ

تستعملین أي أدویة أخرى.

 

أ. لا ینبغي استعمال سِنتوسینون

إذا كانت لدیك أرجیة (حساسیة مفرطة) تجاه أوكسیتوسین أو تجاه

أي من مكونات سِنتوسینون المذكورة في نھایة ھذه النشرة تحت بند

ما ھو سِنتوسینون.

إذا ظن طبیبك أن تحریض أو تشدید الانقباضات غیر مناسب لكِ. مثلاً:

– إذا كانت لدیك بالفعل انقباضات قویة بشكل غیر معتاد (توترمفرط)

– إذا كان الطفل یعاني من نقص الأكسجین )كرب الجنین( ولم تكن الولادة موشكة

– إذا كان الطبیب قد أوصى ضد الولادة الطبیعیة و/أو الولادة من المھبل

– إذا كان ھناك إنسدادات قد تمنع من الولادة.

إذا كانت ھناك أسباب خاصة بالأم أو الجنین تتطلب إجراء عملیة قیصریة. مثلاً:

إذا كانت رأس الطفل أكبر مما یستوعبھ حوض الأم (عدم التناسب بین الرأس

والحوض)

– إذا كان وضع الجنین غیر طبیعي في قناة الولادة (مجيء غیر طبیعي)

– إذا كانت المشیمة تقع بالقرب أو فوق عنق الرحم (مشیمة منزاحة)

– إذا كان الطفل یعاني من نقص الأكسجین بسبب مرور الأوعیة الدمویة عبر عنق الرحم

(أوعیة متقدمة)

– إذا انفصلت المشیمة عن الرحم قبل ولادة الطفل (انفصال المشیمة)

– إذا كان ھناك التفاف واحد أو أكثر من الحبل السُري بین الطفل وعنق الرحم،

قبل نزول الماء (مجيء سُري) أو بعد نزول الماء (تدلِّ الحبل السُري).

– إذا كان الرحم مفرط التمدد وقابل للانفجار (التمزق)، على سبیل المثال إذا

كنت حاملاً في توائم، أو إذا كان لدیك زیادة في الماء (سائل النخط) في الرحم.

– إذا كنت قد حبلتِ خمس مرات أو أكثر سابقاً (كثرة الولادات) أوإذا كانت لدیك

ندبة في الرحم ناتجة عن عملیة قیصریة سابقة أوغیرھا من العملیات الجراحیة.

– إذا كنتِ قد تلقیت أدویة تُسمى بروستاجلاندینات (تُستعمَل لتحفیزالولادة أو علاج

قروح المعدة). لا ینبغي استعمال سِنتوسینون خلال 6 ساعات عقب استعمال

البروستاجلاندینات المھبلیة حیث أن تأثیر كلا الدوائین قد یزداد.

إذا انطبق علیك أي من ھذه الأمور، یجب الامتناع عن أخذ سِنتوسینون ویجب

استشارة الطبیب.

إذا ظننت أن لدیك أرجیة (حساسیة مفرطة) استشیري طبیبك.

 

ب. یجب توخي الحذر الخاص مع سِنتوسینون

یجب إعطاء سِنتوسینون بواسطة متخصص في الرعایة الصحیة، ویجب أن یتم ذلك في إطار

مستشفى حیث یستطیع متخصص الرعایة الصحیة المؤھل أن یراقب انقباضات رحمك وأن

یتعامل بشكل مناسب مع الأمور الطارئة.

 

لا ینبغي استعمال سِنتوسینون لفترات طویلة

إذا فشل في تشدید الانقباضات (عطالة الرحم المقاوِمة لأوكسیتوسین)

• إذا كان لدیكِ ارتفاع في ضغط الدم، وبروتین في البول، وتورم (ما قبل تسمم الحمل)

• إذا كانت لدیكِ مشاكل شدیدة في القلب و/أو الدورة الدمویة (مرض قلبي وعائي شدید)

 

یجب توخي الحذر عند استعمال سِنتوسینون

• إذا كانت لدیك قابلیة لألم الصدر (ذبحة صدریة، ناتجة عن نقص سریان الدم إلى القلب) بسبب

مشاكل مسبقة في القلب و/أو الدورة الدمویة (مرض قلبي وعائي)

• إذا كنت تعرفین بأن لدیك عدم انتظام في ضربات القلب )"متلازمة أو أعراض متعلقة بذلك، أو

إطالة (“QT إذا كنت تأخذین أدویة

معروف عنھا أنھا تسبب ھذه المتلازمة

• إذا تم إعطاؤك حقنة سریعة في الورید، فإنھا قد تسبب انخفاض ضغط

الدم، وحدوث إحساس مفاجئ بالحرارة لفترة وجیزة (توھج)، غالباً في كل أنحاء الجسم، وزیادة

سرعة القلب (تسرع انعكاسي للقلب)

 

عند إعطاء سِنتوسینون لتحفیز وتشدید الولادة:

یتم إعطاؤه فقط بالتنقیط في الورید

• یتم ضبط معدل التنقیط بما یحافظ على نمط الانقباضات مماثلاً للولادة

الطبیعیة ویتم تعدیلھا وفقاً للاستجابة الفردیة. قد تؤدي الجرعات المفرطة إلى انقباضات قویة

جداً ومستمرة )تكزز( مما قد یؤدي إلى انفجار الرحم (تمزق الرحم) وحدوث مضاعفات

خطیرة على الطفل (كرب أو وفاة) وعلیك.

 

یجب توخي الحذر الخاص مع سِنتوسینون:

إذا كان الطبیب أو الدایة قد حذروك من أن الولادة الطبیعیة قد تكون صعبة لأن رأس طفلك

أكبر مما یستوعبھ الحوض (عدم التناسب بین الرأس والحوض)

• إذا بدأت انقباضات الرحم تضعف أثناء الولادة (عطالة ثانویة في الرحم)

• إذا كان لدیك ارتفاع طفیف أو متوسط في ضغط الدم ناجم عن الحمل أو مشاكل في القلب و/أو

الدورة الدمویة (مرض قلبي وعائي)

• إذا كنتِ فوق 35 سنة من العمر

• إذا كنتِ قد أجریت عملیة قیصریة عبر شق فوق حافة المثانة مباشرة

(عملیة قیصریة في القسم السفلي)

• إذا كانت لدیك مشاكل في الكلى (قد یؤدي سِنتوسینون إلى احتباس البول).

• إذا كنتِ قد عانیت من مضاعفات خلال الحمل.

• إذا كانت مدة حملك 40 أسبوعاَ.

• إذا انطبق علیكِ أي من ھذه الأمور، أخبري طبیبك في أقرب وقت

ممكن.

• قد یؤدي سِنتوسینون في أحوال نادرة إلى حدوث تجلط غیر طبیعي للدم، ونزف، وأنیمیا،

(تجلط منتثر داخل الأوعیة الدمویة)

• قد تؤدي الجرعات العالیة من سِنتوسینون إلى دفع سائل النخط من داخل الرحم إلى دورتك

الدمویة (انصمام سائل النخط) أثناء المخاض و/أو الولادة

• قد تؤدي الجرعات العالیة من سِنتوسینون على مدى فترة طویلة مع الشُرب أو تلقي كمیات

كبیرة من السائل إلى:

– امتلاء شدید في البطن وصعوبة في التنفس (وذمة رئویة حادة)

– نقص مستوى الملح (الصودیوم) في الدم (نقص صودیوم الدم)

من حساسیة اللاتكس (مادة المطاط)

– المادة الفعالة في سینتوسینون قد تسبب الحساسیة الشدیدة (الحساسیة المفرطة)

في المرضى الذین یعانون حساسیة من اللاتكس (مادة المطاط) ، یرجى إخبار طبیبك إذا

كنت تعرف أنك تعاني من حساسیة اللاتكس (مادة المطاط)

 

ج. استعمال أدویة أخرى

أخبري طبیبك أو متخصص الرعایة الصحیة عن أي أدویة أخرى تستعملینھا حالیاً أو سبق لك

استعمالھا منذ فترة قصیرة، ویشمل ذلك الأدویة التي قمتِ بشرائھا بدون تذكرة طبیة. من المھم

على نحو خاص أن تخبري طبیبك إذا كنت تتلقین أي من الأدویة التالیة:

• أدویة التخدیر الموضعي أو الناحي لتخفیف الألم، لا سیما التخدیر فوق الجافیة (إعطاء مخدر

موضعي بالحقن حول الحبل الشوكي) لتخفیف الألم أثناء الولادة: قد یؤدي سِنتوسینون إلى

زیادة التأثیر المضیِّق للأوعیة الدمویة الذي تزاوله ھذه الأدویة، مما یؤدي إلى ارتفاع ضغط الدم.

• الأدویة المسماة بالبروستاجلاندینات (تُستعمَل لتحفیز الولادة أو علاج قروح المعدة) والأدویة

المماثلة: قد یؤدي سِنتوسینون إلى زیادة تأثیرھا القابض للرحم.

 • الأدویة التي قد تؤدي إلى عدم انتظام ضربات القلب (إطالة الفترة :(QT قد یؤدي سِنتوسینون

إلى زیادة ھذا التأثیر.

• أدویة التخدیر في شكل غاز أو سائل بخاري یسبب التخدیر العام عند استنشاقه (مثل ھالوثان،

سیكلوبروبان، سیفوفلوران، دیسفلوران) حیث أنھا قد تُضعف تأثیر سِنتوسینون القابض للرحم.

 

د. المسنات ( 65 سنة من العمر فأكثر)

• لا توجد معلومات عن الاستعمال في المریضات المسنات. سِنتوسینون غیر مُصمَّم للاستعمال

في المسنات.

ه. الأطفال والمراھقات ( 2 إلى 17 سنة من العمر)

 • لا توجد معلومات عن الاستعمال في الأطفال ( 2- 11 سنة). سِنتوسینون غیر مُصمَّم للاستعمال

في الأطفال.

• لا توجد معلومات عن الاستعمال في المراھقات ( 17- 12سنة). سِنتوسینون غیر مُصمَّم

للاستعمال في المراھقات.

 

ح. الحمل والإرضاع

الحمل

بناء على الخبرة الواسعة عن ھذا الدواء، وتركیبه الكیمیائي، وخواصه الدوائیة، فمن غیر المتوقَّع

أن یمثل سِنتوسینون أي مخاطرة على الطفل إذا تم استخدامه حسب التعلیمات. یتم استعماله فقط

لتحریض الولادة تحت إشراف طبي.

 

الإرضاع

یتواجد سِنتوسینون بكمیات صغیرة في لبن الثدي ولكن من غیر المتوقَّع أن تكون له آثار ضارة

لأن مفعوله یُبطَل بسرعة في الجھاز الھضمي للرضیع. ھذا یفسر لماذا یُعتبَر سِنتوسینون آمناً

للطفل حدیث الولادة.

اطلبي النصیحة من طبیبكِ، مقدم الرعایة الصحیة أو الصیدلي قبل تناول أي دواء.

 

ط. قیادة السیارة وتشغیل الآلات

قد یؤدي سِنتوسینون إلى تحریض الانقباضات. لذلك یجب توخي الحذر عند قیادة السیارة أو

تشغیل الآلات. یجب على النساء اللاتي لدیھن انقباضات أن یمتنعن عن قیادة السیارة أو تشغیل

الآلات.

https://localhost:44358/Dashboard

استعملي سِنتوسینون تماماً كما وصفه لكِ طبیبكِ أو مقدم الرعایة الصحیة، ینبغي علیكِ الرجوع

إلى طبیبكِ، مقدم الرعایة الصحیة أو الصیدلي في حال لم تكوني متأكدة.

یُعطَى سِنتوسینون بالتنقیط أو بالحقن في الورید. ویجب إعطاؤه في إطار مستشفى حیث یستطیع

متخصص الرعایة الصحیة المؤھل أن یراقب انقباضات رحمك. انظري أیضاً تحت بند یجب

توخي الحذر الخاص مع سِنتوسینون.

 

ما ھي الكمیة التي ینبغي استعمالھا من سِنتوسینون

سیحدد طبیبك أو متخصص الرعایة الصحیة ما ھي الكمیة التي یجب استعمالھا من سِنتوسینون.

لمزید من المعلومات برجاء الرجوع إلى البند 7: معلومات للقائمین على الرعایة الصحیة.

 

متى ینبغي استعمال سِنتوسینون

سیقرر طبیبك متى ینبغي استعمال سِنتوسینون. لمزید من المعلومات راجعي الأمر مع طبیبك أو

مع متخصص الرعایة الصحیة. إذا كان لدیك الانطباع بأن تأثیر سِنتوسینون أقوى أو أضعف مما

ینبغي، تحدثي مع طبیبك أو مع متخصص الرعایة الصحیة.

 

ما ھي طریقة استعمال سِنتوسینون

یتم عادةً تخفیف سِنتوسینون قبل استعماله ویتم إعطاؤه بالتنقیط في الورید أو بالحقن في الورید

بواسطة متخصص في الرعایة الصحیة.

 

ما ھي مدة استعمال سِنتوسینون

سیقرر طبیبك ما ھي مدة استعمال سِنتوسینون. إذا كنتِ غیر متأكدة، اسألي طبیبك أو متخصص

الرعایة الصحیة.

 

أ. إذا أخذت سِنتوسینون بأكثر مما ینبغي

حیث أن ھذا الدواء یُعطَى لكِ في المستشفى، فمن غیر المرجَّح أن یتم إعطاؤك جرعة مفرطة.

غیر أنه إذا حدث ذلك، فإنھا تُعتبر حالة طوارئ ویجب التعامل معھا فوراً في إطار المستشفى.

أي شخص یتلقى ھذا الدواء على سبیل الخطأ یجب أن یذھب فوراً إلى قسم الحوادث والطوارئ

بالمستشفى أو إلى الطبیب، وأن یأخذ معه إن أمكن الدواء المتبقي أو العبوة الفارغة.

الانقباضات المفرطة التي تنتج عن الجرعة الزائدة من سِنتوسینون قد تؤدي إلى العواقب المذكورة

في البند 2 (یجب توخي الحذر الخاص مع سِنتوسینون)

وفي البند 4 (الآثار الجانبیة الممكنة):

• قد تنفصل المشیمة عن الرحم في وقت مبكر (انفصال المشیمة)

• بعض الماء المحیط بالجنین (سائل النخط) قد یندفع إلى الدورة الدمویة

(انصمام سائل النخط)

• قد یعاني طفلك من الكرب، أو الاختناق، أو الوفاة

• قد یتمزق الرحم أو ینفجر (تمزق الرحم)

 

ب. إذا نسیتِ أن تستعملي سِنتوسینون

حیث أن ھذا الدواء یُعطَى فقط في المستشفى بواسطة طبیب أو متخصص في الرعایة الصحیة،

فمن غیر المرجَّح أن تُنسَى إحدى الجرعات.

إذا كان لدیك مزید من الأسئلة عن ھذا المستحضر، برجاء أن تسألي طبیبك أو متخصص الرعایة

الصحیة.

 

 

ج. إذا توقفتِ عن استعمال سِنتوسینون

سیقرر طبیبك متى یجب أن تتوقفي عن تلقي سِنتوسینون. إذا كنتِ غیر متأكدة برجاء أن تسألي

طبیبك أو متخصص الرعایة الصحیة.

یُرجى مراجعة طبیبكِ، مقدم الرعایة الصحیة أو الصیدلي إذا كانت لدیكِ أسئلة أخرى عن طریقة

استعمال الدواء.

شأنه شأن جمیع الأدویة، فمن الممكن أن تحدث آثار جانبیة مع سِنتوسینون، غیر أنھا لا تحدث

لجمیع الأشخاص.

قد یرى طبیبك أنھ من الضروري علاج الآثار الجانبیة لسِنتوسینون باستخدام أدویة أخرى.

 

بعض الآثار الجانبیة قد تكون خطیرة

بعض الآثار الجانبیة تكون نادرة

الأثر الجانبي التالي قد یصیب بین 1 و 10 من كل 1000 مریضة:

• تفاعل أرجي شدید (تفاعل تأقي) مصحوب بضیق في التنفس، انخفاض

ضغط الدم، أو انخفاض خطیر في ضغط الدم (صدمة).

 

لا یُعرَف ما ھي نسبة المریضات اللاتي قد یتعرضن لحدوث الآثار الجانبیة

الخطیرة التالیة

آثار في الأم

• ألم في الصدر بسبب نقص سریان الدم إلى القلب (ذبحة)

• عدم انتظام في ضربات القلب (إطالة الفترة(QTc

• انقباضات مفرطة (فرط التوتر)

• انقباض مستمر (تكزز)

• انفجار الرحم (تمزق الرحم)

• احتجاز السوائل (التسمم بالماء)

• نقص مستوى الصودیوم (الملح) في الدم

• تحمیل مفرط حاد للسوائل في الرئتین (وذمة رئویة حادة)

• إحساس مفاجئ بالحرارة لفترة وجیزة، غالباً في كل أنحاء الجسم (توھج)

• تجلط غیر طبیعي للدم، ونزف، وأنیمیا (تجلط منتثر داخل الأوعیة الدمویة)

• تورم الوجه، الشفاه، اللسان، الحلقظن و/أو الأطراف (علامات ممكنة للوذمة الوعائیة).

إذا حدث لكِ أي من ھذه الأمور، أخبري طبیبك فوراً.

آثار في الطفل

قد تؤدي الانقباضات الزائدة إلى حدوث ما یلي:

• نقص مستوى الصودیوم (الملح) في الدم (نقص صودیوم الدم الولیدي)

• الحرمان من الأكسجین (كرب الجنین)

• الاختناق بسبب قلة الأكسجین و/أو زیادة ثاني أكسید الكربون (اختناق)

• الوفاة

إذا حدثت إصابة شدیدة بأي من ھذه الأمور، أخبري طبیبك فوراً.

 

بعض الآثار الجانبیة تكون شائعة

ھذه الآثار الجانبیة قد تصیب بین 1 و 10 من كل 100 مریضة.

• صداع

• تسرع ضربات القلب

• بطء ضربات القلب

• غثیان

• قيء

إذا حدثت لكِ إصابة شدیدة بأي من ھذه الأمور، أخبري طبیبك.

 

بعض الآثار الجانبیة تكون غیر شائعة

ھذا الأثر الجانبي قد یصیب بین 1 و 10 من كل 1000 مریضة.

• عدم انتظام ضربات القلب (اضطراب النظم القلبي)

إذا حدثت لكِ إصابة شدیدة بأي من ھذه الأمور، أخبري طبیبك.

 

 

 

 

 

بعض الآثار الجانبیة تكون نادرة

ھذا الأثر الجانبي قد یصیب بین 1 و 10 من كل 10000 مریضة.

• طفح جلدي.

إذا حدثت لكِ إصابة شدیدة بأي من ھذه الأمور، أخبري طبیبك.

إذا لاحظت أي آثار جانبیة أخرى غیر مذكورة في ھذه النشرة، برجاء أن

تخبري طبیبك أو الصیدلي.

 

سِنتوسینون محلول للحقن: یُحفَظ في الثلاجة ( 2-°8 م).

یجب حفظ سِنتوسینون بعیداً عن متناول ومرأى الأطفال.

لا یُستعمل سِنتوسینون بعد تاریخ انتھاء الصلاحیة المذكور على العبوة. تاریخ الإنتھاء یُشیر إلى

آخر یوم من الشھر المذكور.

ھذه المعلومات قد تختلف في بعض البلاد.

 المادة الفعالة في سِنتوسینون ھي أوكسیتوسین

المكونات الأخرى ھي:

خلات صودیوم ثلاثي التمیؤ، حمض خلیك ثلجي، كلوروبیوتانول، إیثانول 94 % ، ماء للحقن.

ب. ماذا یبدو سِنتوسینون:

سِنتوسینون محلول معقم عدیم اللون وعالي الوضوح ویتم توفیره كمحلول

للحقن في أمبولات. كل حزمة تحتوي على أمبولات 5 × 1مل 

ھذه المعلومات قد تختلف في بعض البلاد.

 

ج. مالك حق التسویق

میلان فارما المحدودة

، ترمستراس 24

6312 شتاینھاوسن، سویسرا

 

مصنع:

ستیریساینس شركة خاصة محدودة

یو.ال. دانزیوسكا . 230,10-03 وارسو, بولند

 

دیسمبر 2021
 Read this leaflet carefully before you start using this product as it contains important information for you

SYNTOCINON 5 IU concentrate for solution for infusion / solution for injection

1 ml of solution for injection (one ampoule) contains 5 IU of synthetic oxytocin. Excipients: ethanol 94% (5 mg/ml) For the full list of excipients, see section 6.1.

Concentrate for solution for infusion / solution for injection Sterile, clear colourless solution

4.1 Therapeutic indications
Antepartum
- Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of
the membranes, pregnancy-induced hypertension (pre-eclampsia).
- Stimulation of labour in hypotonic uterine inertia
- Syntocinon may also be indicated in early stage of pregnancy, as adjunctive therapy for
management of incomplete, inevitable or missed abortion.
Postpartum
- During caesarean section, but after the delivery of thechild.
- Prevention and treatment of postpartum haemorrhage related to uterineatony.


4.2 Posology and method of administration
Dosing
General target population
Induction or enhancement of labour
Syntocinon is given as an intravenous drip infusion or, preferably, by means of a variable-speed infusion pump.
For drip infusion it is recommended that 5 IU of Syntocinon be added to 500 ml of a physiological electrolyte
solution (such as sodium chloride 9 mg/ml). For patients in whom infusion of sodium chloride must is
contraindicated (see
section 4.4), 50 mg/ml dextrose solution may be used. To ensure even mixing, the bottle or bag must be turned
upside down several times before use.
The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be increased
gradually at intervals not shorter than 20 minutes and increments of not more than 1–2 milliunits/minute until a
contraction pattern similar to that of normal labour is established. In pregnancy near term, this can often be
achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum
rate is 20 milliunits/minute
(40 drops/minute). In the unusual event of higher rates being required, as may occur in the management of foetal
death in utero or for induction of labour at an earlier stage of pregnancy when the uterus is less sensitive to
oxytocin, it is advisable to use a more concentrated Syntocinon solution, e.g. 10 IU in 500 ml.
When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the
concentration suitable for infusion within the recommended dosage range must be calculated according to the
specifications of the pump.
The frequency, strength and duration of contractions and also the fetal heart rate must be carefully monitored
throughout the infusion. Once an adequate level of uterine activity is attained, the infusion rate can often be
reduced. In the event of uterine hyperactivity and/or fetal distress, the infusion must be discontinued immediately.
If, in women who are at term or near term, regular contractions are not established after the infusion of a total
amount of 5 IU, it is recommended that the attempt to induce labour should be terminated; it may be repeated on
the following day, starting again from a rate of 1 to milliunits/minute.
Incomplete, inevitable, or missed abortion
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or,
preferably, by means of a variable-speed infusion pump over 5 minutes) or 5 IU to 10 IU i.m., followed by i.v.
infusion at a rate of 20 to 40 milliunits/minute, if necessary.
Caesarean section
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or,
preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.
Prevention of postpartum uterine haemorrhage
The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v.
drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) or 5 IU to 10 IU i.m. after
delivery of the placenta.
In women given Syntocinon for induction or enhancement of labour, the infusion should be continued at an
increased rate during the third stage of labour and for the next few hours thereafter.
Treatment of postpartum uterine haemorrhage
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or,
preferably, by means of a variable-speed infusion pump over 5 minutes), or 5 IU to 10 IU i.m., followed in severe
cases by intravenous infusion of a solution containing 5IU to 20 IU of oxytocin in 500 ml of an electrolytecontaining
diluent, run at the rate necessary to control uterine atony.
Special populations
Renal impairment
No studies have been performed in renally impaired patients.
Hepatic impairment
No studies have been performed in hepatically impaired patients.
Pediatric population
No studies have been performed in pediatric patients.
Geriatric patients
No studies have been performed in elderly patients (aged 65 years and over).


4.3 Contraindications  Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.  Hypertonic uterine contractions, foetal distress when delivery is not imminent. Any condition in which, for foetal or maternal reasons, spontaneous labour is unadvisable and/or vaginal delivery is contraindicated: e.g.:  cephalopelvic disproportion,  fetal malpresentation,  placenta praevia, vasa praevia,  placental abruption,  cord presentation or prolapse;  overdistension or impaired resistance of the uterus to rupture as in multiple pregnancy,  polyhydramnios,  grand multiparity and  in the presence of a uterine scar resulting from major surgery including classical caesarean section Syntocinon must not be administered within 6 hours after vaginal prostaglandins have been given (see section 4.5).

4.4 Special warnings and precautions for use
Induction of labour
The induction of labour by means of oxytocin should be attempted only when strictly indicated for medical reasons
rather than for convenience. Administration should only be under hospital conditions and qualified medical
supervision.
Syntocinon should not be used for prolonged periods in patients with oxytocin-resistant uterine inertia, severe preeclamptic
toxemia or severe cardiovascular disorders.
Syntocinon should not be given as i.v. bolus injection as it may cause an acute short-lasting hypotension
accompanied with flushing and reflex tachycardia.
Cardiovascular disorders
Syntocinon should be used with caution in patients who have a pre-disposition to myocardial ischemia due to
pre- existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or
ischemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure
and heart rate.
QT Syndrome
Syntocinon should be given with caution to patients with known ‘long QT syndrome’ or related symptoms and to
patients taking drugs that are known to prolong the QTc interval (see section 4.5).
When Syntocinon is given for induction and enhancement of labour:
- It must only be administered as an i.v. infusion, and never by s.c., i.m. or i.v. injection.
- Fetal distress and fetal death: Administration of oxytocin at excessive doses results in uterine overstimulation
which may cause foetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or
rupture of the uterus. Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and
duration of contractions) is essential, so that the dosage may be adjusted to individual response.
- Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine
inertia, mild or moderate degrees of pregnancy-induced hypertension or cardiac disease and in patients above
35 years of age or with a history of lower-uterine-segment caesareansection.
- Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labour
using uterotonic agents including oxytocin increases the risk of post partum disseminated intravascular
coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk.
This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years
of age or over, complications during the pregnancy and gestational age more than 40 weeks. In these
women, oxytocin or any other alternative drug should be used with care, and the practitioner should be
alerted by signs of DIC.
Intrauterine death
In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labour
must be avoided, as it may cause amniotic fluid embolism.
Water intoxication
Because oxytocin possesses slight antidiuretic activity, its prolonged i.v. administration at high doses in conjunction
with large volumes of fluid (as may be the case in the treatment of inevitable or missed abortion, or in the
management of postpartum hemorrhage) may cause water intoxication associated with hyponatraemia. The
combined antidiuretic effect of oxytocin and the i.v. fluid administration may cause fluid overload leading to a
hemodynamic form of acute pulmonary edema without hyponatraemia. To avoid these rare complications, the
following precautions must be observed whenever high doses of oxytocin are administered over a long time: an
electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by
infusing oxytocin at a higher concentration than recommended for the induction or enhancement of labour at term);
fluid intake by mouth must be restricted; a fluid balance chart should be kept and serum electrolytes should be
measured when electrolyte imbalance is suspected.
Caution should be exercised in patients with severe renal impairment because of possible water intoxication and
possible accumulation of oxytocin (see section 5.1).
This medication contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Anaphylaxis in women with latex allergy:
There have been reports of anaphylaxis following administration of oxytocin in women with a known latex
allergy. Due to the existing structural homology between oxytocin and latex, latex allergy/intolerance may be
an important predisposing risk factor for anaphylaxis following oxytocin administration.


4.5 Interaction with other medicinal products and other forms of interaction
Interaction resulting in a concomitant use not recommended
Prostaglandins and their analogues
Prostaglandins and their analogues facilitate contraction of the myometrium hence oxytocin can potentiate the uterine
action of prostaglandins and analogues and vice versa (see section 4.3).
Drugs prolonging the QT interval
Oxytocin should be considered as potentially arrhythmogenic, particularly in patients with other risk factors for torsades
de pointes such as drugs which prolong the QT interval or in patients with history of long QT syndrome (see section
4.4).
Interactions to be considered
Inhalation anesthetics
Inhalation anesthetics (e.g. cyclopropane, halothane, sevoflurane and desflurane) have a relaxing effect on uterus and
produce a notable inhibition of uterine tone and thereby, may diminish the uterotonic effect of oxytocin.
Vasoconstrictors/sympathomimetics
Oxytocin may enhance the vasopressor effects of vasoconstrictors and sympathomimetics, even those
contained in local anesthetics.
Caudal anesthetics
When given during or after caudal block anesthesia, oxytocin may potentiate the pressor effect of
sympathomimetic vasoconstrictor agents.


4.6 Fertility, Pregnancy and lactation
Women of childbearing potential
Not applicable for Syntocinon because of the nature of the indications.
Pregnancy
Pre-clinical data for oxytocin reveal no special hazard based on conventional studies of single dose acute
toxicity, genotoxicity, and mutagenicity. No standard teratogenicity and reproductive performance studies with
oxytocin are available (see section 5.3). Based on the wide experience with this drug and its chemical structure
and pharmacological properties, it is not expected to present a risk of fetal abnormalities when used as
indicated.
Breast-feeding
Oxytocin may be found in small quantities in mother’s breast milk. However, oxytocin is not expected to cause
harmful effects in the newborn because it passes into the alimentary tract where it undergoes rapid inactivation.
Fertility
Not applicable for Syntocinon because of the nature of the indications.


Not applicable.


Summary of the safety profile
When oxytocin is used by i.v. infusion for the induction or enhancement of labour, its administration at excessive
doses results in uterine overstimulation which may cause foetal distress, asphyxia and death, or may lead to
hypertonicity, tetanic contractions or rupture of the uterus.
Rapid i.v. bolus injection of oxytocin at doses amounting to several IU may result in acute short-lasting
hypotension accompanied with flushing and reflex tachycardia (see section 4.4). These rapid hemodynamic
changes may result in myocardial ischemia, particularly in patients with pre-existing cardiovascular disease.
Rapid i.v. bolus injection of oxytocin at doses amounting to several IU may also lead to QT prolongation.
In rare circumstances (i.e. incidence rate less than 0.0006), the pharmacological induction of labour using uterotonic
agents, including oxytocin, increases the risk of postpartum disseminated intravascular coagulation (see section 4.4).
Tabulated list of adverse reactions
The following adverse drug reactions have been reported regardless of the mode of administration:
Adverse reactions (Tables 1 and 2) are ranked under heading of frequency, using the following convention:
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <
1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data.
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. The
adverse reactions tabulated below are based on clinical trial results as well as postmarketing reports.
The adverse drug reactions that have been derived from post-marketing experience with Syntocinon are via
spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a
population of uncertain size, it is not possible to reliably estimate their frequency which is therefore
categorized as not known.
Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ
class, adverse drug reactions are presented in order of decreasing seriousness.
Table 1 Adverse drug reactions in
mother Immune system disorders
Rare: anaphylactoid reaction associated with dyspnoea,
Hypotension or shock
Nervous system disorders
Common: headache
Cardiac disorders
Common: tachycardia, bradycardia
Uncommon: arrhythmia
Not known: myocardial ischemia, QTc prolongation
Vascular disorders
Not known: hypotension
Gastrointestinal disorders
Common: nausea, vomiting
Skin and subcutaneous tissue disorders
Rare: rash
Pregnancy, puerperium and perinatal conditions
Not known: uterine hypertonicity, tetanic contractions, rupture of the uterus
Metabolism and nutrition disorders
Not known: water intoxication, maternal hyponatraemia
Respiratory, thoracic and mediastinal disorders
Not known: acute pulmonary oedema
General disorders and administration site conditions
Not known: flushing
Blood and lymphatic system disorders
Not known: disseminated intravascular coagulation
Table 2 Adverse drug reactions in
fetus/neonate Pregnancy, puerperium and
perinatal conditions
Not known: foetal distress, asphyxia and death
Metabolism and nutrition
disorders
Not known: neonatal hyponatraemia
Description of selected adverse reactions
Water intoxication
Water intoxication associated with maternal and neonatal hyponatraemia has been reported in cases where high
doses of oxytocin have been administered together with large amounts of electrolyte-free fluid over a prolonged
period of time (see section 4.4).
The combined antidiuretic effect of oxytocin and the i.v. fluid administration may cause fluid overload leading to a
hemodynamic form of acute pulmonary edema without hyponatraemia (see section 4.4).


4.9 Overdose
The symptoms and consequences of overdose are those mentioned under section 4.4 Special warnings and
precautions for use and section 4.8 Undesirable effects. In addition, placental abruption and/or amniotic fluid
embolism as a result of uterine overstimulation have been reported.
Treatment
When signs or symptoms of overdose occur during i.v. administration of Syntocinon, the infusion must be
discontinued at once and oxygen should be given to the mother. In the event of water intoxication, it is essential to
restrict fluid intake, promote diuresis, correct electrolyte imbalance; and control possible convulsions.


5.1 Pharmacodynamic properties
- Pharmacotherapeutic group: Posterior pituitary lobe hormones, ATC code: H01B B02
-Mechanism of action & Pharmacodynamic effects:
Oxytocin is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the
natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to
suckling and labor. Oxytocin stimulates the smooth muscle of the uterus, more powerfully towards the end of
pregnancy, during
labor, and immediately postpartum. At these times, the oxytocin receptors in the myometrium are increased. The
oxytocin receptors are G-proteins coupled receptors. Activation of receptor by oxytocin triggers release of calcium
from intracellular stores and thus leads to myometrial contraction Oxytocin elicits rhythmic contractions in upper
segment of uterus, similar in frequency, force and duration to those observed during labor. Being synthetic,
oxytocin in Syntocinon does not contain vasopressin, But even in its pure form oxytocin possesses some weak
intrinsic vasopressin-like antidiuretic activity.
Based on in vitro studies, prolonged exposure of oxytocin causes desensitization of oxytocin receptors probably due
to down-regulation of oxytocin-binding sites, destabilization of oxytocin receptors mRNA and internalization of
oxytocin receptors.
Plasma levels and onset/duration of effect
Intravenous infusion: When Syntocinon is given by i.v. infusion at doses appropriate for induction or enhancement
of labor, the uterine response sets in gradually and usually reaches a steady state within 20 to 40 minutes. The
corresponding plasma levels of oxytocin are comparable to those measured during spontaneous first-stage labour.
Upon discontinuation of the infusion, or following a substantial reduction in the infusion rate, e.g. in the event of
overstimulation, uterine activity declines rapidly but may continue at an adequate lower level.
Intravenous injection and intramuscular injection: When administered by i.v. or i.m. injection for
prevention or treatment of postpartum hemorrhage, Syntocinon acts rapidly with a latency period of less than 1
minute by i.v. injection, and of 2 to 4 minutes by i.m. injection. The oxytocic response lasts for 30 to 60 minutes
after i.m. administration, possibly less after i.v. injection.


5.2 Pharmacokinetic properties
Oxytocin
Absorption
Oxytocin is rapidly absorbed from the i.m. site. Plasma levels of oxytocin following intravenous infusion
at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/ml.
Distribution
The steady-state volume of distribution determined in 6 healthy men after i.v. injection is 12.2 L or 0.17 L/kg.
Plasma protein binding is negligible for oxytocin. Oxytocin crosses the placenta in both directions. It may be
found in small quantities in mother’s breast milk.
Biotransformation
Oxytocinase is a glycoprotein aminopeptidase that is produced during pregnancy and appears in the plasma. It
is capable of degrading oxytocin. It is produced from both the mother and the fetus. Liver and kidney plays a
major role in metabolizing and clearing oxytocin from the plasma. Thus, liver, kidney and systemic circulation
contribute to the biotransformation of oxytocin.
Elimination
Plasma half life of oxytocin ranges from 3 to 20 minutes. The metabolites are excreted in urine whereas
lessthan 1% of the oxytocin is excreted unchanged in urine. The metabolic clearance rate amounts to 20
ml/kg/min in the pregnant woman.
Renal impairment
No studies have been performed in renally impaired patients. However considering the excretion of oxytocin
and its reduced excretion in urine due to anti-diuretic properties, the possible accumulation of oxytocin can
result in prolonged action of oxytocin.
Hepatic impairment
No studies have been performed in hepatically impaired patients. Pharmacokinetic alteration in patients with
impaired hepatic function is unlikely since metabolizing enzyme, oxytocinase, is not confined to liver alone and
the oxytocinase levels in placenta during the term has significantly increased. Therefore, biotransformation of
oxytocin in impaired hepatic function may not result in substantial changes in metabolic clearance of oxytocin
(see section 4.4).
Clinical studies
Syntocinon is an established product. No recent clinical studies are available.


5.3 Preclinical safety data
Pre-clinical data for oxytocin reveal no special hazard for humans based on studies of single dose acute
toxicity, genotoxicity, and mutagenicity.
Mutagenicity
An in vitro genotoxicity and mutagenicity study with oxytocin has been reported. Tests were negative for
chromosomal aberration and sister chromatid exchange in human peripheral lymphocyte cultures. No
significant changes in the mitotic index were noticed. Oxytocin had no genotoxic properties. The genotoxic
potential of oxytocin has not been determined in vivo.
Carcinogenicity, teratogenicity and reproduction toxicity
Treatment of rats with oxytocin in early pregnancy at doses considered sufficiently in excess of the
maximum recommended human dose caused embryonic loss in one study.
No standard teratogenicity, reproductive performance and carcinogenicity studies with oxytocin are available.


6.1 List of excipients
sodium acetate
trihydrate glacial
acetic acid
chlorobutanol
ethanol 94%
water for injections


In the absence of compatibility studies, Syntocinon must not be mixed with other medicinal products.


60 months

Store in a refrigerator (2 °C - 8 °C).


Package with 10 carton boxes, each comprising 10 colourless glass (type I) ampoules (10 x 10), each
containing 1 ml (5 IU/ml).
Package with 10 carton boxes, each comprising 10 colourless glass (type I) ampoules (10 x 10), each
containing 1 ml (10 IU/ml).


No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Mylan Pharma GmbH Turmstrasse 24, 6312 Steinhausen, Switzerland Tel. +41 (0)41 768 48 48 Fax. +41 (0)41 768 48 49 e-mail: info.ch@mylan.com

December 2018
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